Show #39, May 2005
Show #39, May 2005
|New Drug to Treat Type 1 and Type 2 Diabetes|
FDA recently approved a new injectable drug to help control blood sugar in adult patients with Type 1 and Type 2 diabetes. It's called Symlin, or pramlintide acetate, and it's manufactured by Amylin Pharmaceuticals.
Symlin is used in addition to insulin to help reduce postprandial blood sugar levels in patients who can't achieve adequate control despite optimal insulin therapy. Tighter control of blood sugar may help reduce the risk of long-term renal, cardiovascular and ocular events in these patients.
Although patients with Type 2 diabetes already have drug therapy other than insulin to help control blood sugar, Symlin will be the only therapy available other than insulin for Type 1 patients.
The FDA and the manufacturer have some safety concerns about Symlin. First, the drug may increase the risk of hypoglycemia. This risk is greatest in Type 1 diabetics and in those with gastroparesis. Second, patients might mix Symlin with insulin in the same syringe, which can alter the activity of the insulin. And third, the drug might be used inappropriately in patient populations where the risk / benefit profile hasn't been established.
To help resolve these concerns, FDA is requiring that patients receive a Medication Guide with each prescription that explains the risks and how to use the drug properly.
The guide tells patients they must be using their insulin as prescribed, must follow their doctor's instructions on using the drug, must be followed up frequently, and that they must test their blood sugar before and after every meal and at bedtime.
The labeling for physicians will specify that Symlin not be used in patients with gastroparesis, or those allergic to any of the drug's ingredients.
|Recall of Certain Heartsine AEDs|
HeartSine Technologies is recalling some of its samaritan® Automatic External Defibrillators. The affected devices may shut down before delivering a shock, which could delay treatment or even lead to death of a viable patient. We've received several user complaints that the device shut down during an attempted charge, but no injuries have been reported to date.
This recall includes models SAM-001, SAM-002, and SAM-003 with certain serial numbers within the range of 1270 - 2324. The HeartSine samaritan® PAD automatic external defibrillator is not affected by this recall.
HeartSine Technologies notified its distributors and customers by letter on February 14, 2005, and the company is providing a software upgrade for the affected devices. If you have a device within this serial number range, but have not yet received an upgrade kit, you should contact the company as soon as possible to see if your product is affected and to get the kit. Go to our web site for details on how to contact the company.
|Warning on Using Gabitril in Patients Without Epilepsy|
FDA is requiring that a new Bolded Warning be added to the labeling for Gabitril (tiagabine) an antiepileptic drug that's approved as adjunctive therapy in treating partial seizures. The warning is being issued because of reports that Gabitril has been associated with seizures in more than 30 patients who received it for conditions other than epilepsy.
Although Gabitril is approved only for treating epilepsy, it's been used off-label for treating other conditions, mainly psychiatric illnesses and chronic pain, and it's those uses where the seizures have occurred.
This could pose a confusing situation for practitioners: a drug that's used to control seizures in patients with epilepsy that could be causing seizures in other patients. In fact, an FDA Advisory notes that in some cases, prescribers have actually increased the dose of Gabitril when their patients without epilepsy started having seizures. Presumably they weren't aware that it was the Gabitril that might be causing the seizures, and they may have thought that since the drug is an anti-epileptic, it might control the seizures in these other patients.
Gabitril’s manufacturer is changing the labeling to reflect this risk, and they've also agreed to undertake an educational campaign for both physicians and patients, making people aware of the risks and discouraging off-label use.
The FDA Advisory reminds practitioners that Gabitril has not been approved for conditions other than epilepsy, and that using it for these conditions constitutes an off-label use. The Advisory says that if a practitioner does decide to use the drug off-label, the risk of seizures should be explained to the patient.
|Warning on Vail Patient Beds|
Here's a warning about certain enclosed beds that could be hazardous to patients. They're made by Vail Products Inc. of Toledo, Ohio.
On March 22, the FDA and the Justice Department initiated a seizure of all Vail model 500, 1000, and 2000 enclosed bed systems, because patients can become entrapped in the beds and suffocate.
These canopy-like padded beds are used for at-risk patients with cognitive impairment, unpredictable behavior, spasms, seizures, and other disorders. They're advertised as an alternative to using a physical restraint or medication to reduce falls and prevent wandering.
About 30 adverse events, including at least 7 deaths, have occurred from entrapments, falls, and other incidents with these beds. More than half of these events involved children age 16 and under.
FDA recommends that hospitals, nursing homes, and consumers who have a Vail enclosed bed system stop using it immediately and move the patient to an alternate bed.
If the only option for the patient is to continue using the Vail bed, FDA currently recommends that users follow these safety precautions, recommended by Vail:
- Use only the mattress recommended by the company.
- Always leave the side rails in the “up” position except when moving the patient from the bed.
- If the bed has a Hi-Lo feature that raises and lowers the entire bed surface, never leave the feature in the "Hi" position while the patient is unattended, because the patient can become entrapped.
The company may take additional steps to address these safety issues. Check our web site for additional information and for updates as they become available.
|Updated Safety Information for Crestor|
FDA recently provided health care practitioners and patients with updated information about the risks and benefits of Crestor (rosuvastatin calcium), a cholesterol-lowering drug made by Astra-Zeneca Pharmaceuticals.
Crestor, like all other statins, has been associated with rhabdomyolysis. The incidence of this effect is low, and the risk of serious muscle damage doesn't appear to be greater for Crestor than for other statins.
But as with all statins, the risk of myopathy increases with higher drug levels. So Crestor's labeling has been changed to re-emphasize the risk of myopathy, particularly at the highest approved dose of 40 mg. The labeling also stresses the need to consider using lower starting doses in some patients.
This may be particularly important when treating Asian Americans, since a large pharmacokinetic study found that this group of patients had drug levels about twice as high as a Caucasian control group, and that could increase their risk for myopathy. The revised labeling now recommends that the 5 mg dose of Crestor be considered as the starting dose for Asian-Americans, and also for others with predisposing factors for myopathy, including patients on cyclosporine and those with severe renal insufficiency.
|FDA Advisory on Adderall|
FDA recently issued a Public Health Advisory describing reports of sudden unexplained death in children taking Adderall and Adderall XR, which are used to treat ADHD.
Sudden death has been reported in children with underlying cardiac abnormalities who are taking recommended doses of amphetamines, including Adderall and Adderall XR. A very small number of cases of sudden death have been reported in children without cardiac abnormalities taking Adderall.
At this time, it doesn't appear that the number of sudden deaths in children taking Adderall is greater than the number that would be expected in this population without treatment. But it's possible that patients with underlying heart defects might be especially at risk, and so the advisory reemphasizes the warning in the product labeling that these patients should ordinarily not be treated with Adderall products.
|Possible Cancer Risk with Certain Topical Eczema Drugs|
FDA recently advised health care professionals and patients about a potential cancer risk from two topical immunosuppressant products used to treat atopic dermatitis (eczema). The drugs are Elidel (pimecro-limus) and Protopic(tacro-limus).
The advisory cautioned that these products should be used only as directed and only after other eczema treatments have failed. FDA is also adding a boxed warning to the labeling for these two products and developing a Medication Guide for patients.
The concern about possible cancer risk is based on information from animal studies, on case reports in a small number of patients, and on the drugs' mechanism of action. Long term human studies may be needed to determine whether Elidel or Protopic pose a cancer risk in humans, and the extent of the risk, if any. In the meantime, FDA has several recommendations to help minimize the risk.
First, use Elidel and Protopic only as second-line agents for treatment of eczema in patients who have failed or can't tolerate other prescription treatments.
Use Elidel and Protopic only for short periods of time, not continuously. The long term safety of these drugs is unknown.
Use the minimum amount of Elidel or Protopic needed to control the patient's signs and symptoms. In animals, increasing the dose resulted in higher rates of cancer.
Do not use these drugs in children and adults with a weakened or compromised immune system.
And finally, avoid using these drugs in children younger than 2 years of age. Elidel and Protopic are not approved for this use, and the effect of these drugs on the developing immune system in infants and children is not known.
|Warning on Using Phenergan in Children Under Two|
The FDA and Wyeth have notified health care professionals that Phenergan tablets and suppositories are contraindicated in children under the age of two because the drug could cause fatal respiratory depression.
The labeling also warns practitioners to be cautious when using Phenergan in older children. It notes that respiratory depression can also occur in this age group, even when the dose has been calculated according to the child's weight. The risk is increased when Phenergan is used concomitantly with other drugs that may cause respiratory depression.
The labeling goes on to remind practitioners that antiemetics such as Phenergan are not recommended for treating uncomplicated vomiting in children. Another reason to avoid using Phenergan in children is that it can cause extrapyramidal symptoms that can be mistaken for the CNS signs of diseases such as encephalopathy or Reye's Syndrome.
|New Rule Enhances the Safety of Human Cells and Tissues|
FDA recently finalized a new rule that's designed to increase the safety of human cells, tissues and cellular and tissue-based products that are used for transplantation. The regulations apply to a broad range of products, including bone, ligaments, skin, corneas, and hematopoietic stem cells. They also apply to human heart valve and human dura mater allografts. The rule requires that manufacturers of these products recover, process, store, label, package and distribute them in a way that prevents the spread of communicable diseases.
In this rule, FDA uses the word "manufacture" as an umbrella term to capture the many different actions an establishment might take in preparing these products for use. Many types of establishments may be involved in various steps from recovery, donor screening and testing, to storage and distribution. If an establishment is involved in any of the steps covered by the new regulation, FDA calls it a manufacturer.
Prior to the new rule, there were some regulations in place to help assure the safety of human tissue. But the new rule covers a broader range of products and has more comprehensive requirements. This will help assure health care providers that the tissue and cellular products they use are the safest available.
If you use these products, you can help us monitor their safety by reporting any serious or life-threatening adverse reactions in your patients. You can find out how to report on our web site.
FDA Patient Safety News is a product of the US Federal Government, and as such is NOT copyrighted or restricted in any way. We encourage the further use and distribution of the video or text of the program by anyone – either in its entirety or as individual stories.